21 CFR Subpart B
Applications
June 25, 2020
§
314.54
Procedure for submission of a 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug
§
314.55
Pediatric use information
§
314.60
Amendments to an unapproved NDA, supplement, or resubmission
§
314.50
Content and format of an NDA
§
314.52
Notice of certification of invalidity, unenforceability, or noninfringement of a patent
§
314.53
Submission of patent information
§
314.65
Withdrawal by the applicant of an unapproved application
§
314.70
Supplements and other changes to an approved NDA
§
314.71
Procedures for submission of a supplement to an approved application
§
314.72
Change in ownership of an application
§
314.80
Postmarketing reporting of adverse drug experiences
§
314.81
Other postmarketing reports
§
314.90
Waivers
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